Regulatory compliance expertise delivered during the initial start-up activities was of major benefit in meeting our requirements and the requirements of our customer. Quality System and Product Certification expertise provided enabled the delivery of future customer requirements. Experience in the field of QA, expertise and training in Six Sigma and hands on approach to Project Management and Implementation has proved to be an invaluable consulting asset to Clada Medical Devices. Knowledge in all aspects of Medical Device Design, manufacture and validation has had a serious positive impact on Project completion and cost.